Efficacy and Safety of Organoid-Based Drug Sensitivity Screening to Guide the Treatment of mCRPC Patients Progressed After First-line Treatment

Sun Yat-sen University

Status: Enrolling

Conditions: Metastatic Castration-resistant Prostate Cancer

Treatments: Other: Organoid-Based Drug Sensitivity Screening

Study type: Observational

Funder types: Other

Identifiers

NCT06529549

2024-FXY-231

Details and patient eligibility

About

This observational study aims to learn about the effects and safety of organoid-based drug sensitivity screening in mCRPC patients with bone metastases that progressed after first-line treatment. The main question it seeks to answer is:

Do doctors choose treatment agents based on organoid-based drug sensitivity screening results for mCRPC patients, resulting in a better response?

Participants already took bone metastasis biopsies for genetic testing based on current clinical guidelines. This study only takes residual tissue from biopsies for organoid culture.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Willing and able to provide informed consent.
2. Adult males from 18 to 75 years age.
3. History of histologically or cytologically confirmed adenocarcinoma
4. Documented evidence of metastatic castration resistant prostate cancer (mCRPC) and progressed after first-line treatment at mCRPC.
5. Evidence of target lesion in imaging studies.
6. ECOG performance status 0-1
7. Estimated survival≥12 weeks

Exclusion criteria

1. Do not meet the inclusion criteria.
2. Under any other anti-tumor therapy like chemotherapy and/or immunotherapy.
3. Receiving organ transplantation in the last 3 months.
4. Participants with autoimmune diseases or history of HBV, HCV or HIV infection (acute).
5. Participants with pneumonia.
6. Severe concurrent illness or co-morbid disease that would make the subject unsuitable for enrolment
7. Unwilling and unable to provide informed consent.
8. Patients who are judged unsuitable for clinical trial participation by the investigators.

Trial design

30 participants in 1 patient group

Organoid-Based Drug Sensitivity Screening

Description:

Organoid culture and drug sensitivity screening

Treatment:

Other: Organoid-Based Drug Sensitivity Screening